The CTI PET Systems Inc. ECAT HRRT positron emission tomography (PET) scanners are intended to be utilized by appropriately trained health care professionals to image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic and physiologic functions within the human body.

Device Description

The CTI PET Systems ECAT HRRT is a new positron emission tomography (PET) scanner system. The ECAT HRRT PET scanners utilize flat panel detector heads, combined LSO (Lutetium Oxyortho-Silicate) / LYSO (Lutetium Yttrium Oxyortho-Silicate) crystal detector technology. The HRRT consists of eight detector panels in an octagonal arrangement completely encircling the bore of the Gantry. A Patient Handling System (PHS) will be offered as an optional accessory with the scanner. This PHS is similar to other PHS systems currently marketed with the exception that it has been specifically designed for use with the HRRT. Modifications have been made to accommodate the different size gantry bore and shorter horizontal travel associated with this gantry. The acquisition computer system is comprised of an Intel based acquisition PC, a Raid system disk and a console connected via fibre channel to the HRRT electronics. This is the same as is used in the ECAT ACCEL (K002584) with the exception of the RAID disk. Software is based on the Standard ECAT software (7.x), which is used with the ECAT ACCEL system. Modifications have been made to accommodate the new acquisition system, enlarged data sets (due to increased resolution) and user interface to allow clinician flexibility in reconstruction.

AI/ML Overview

Acceptance Criteria and Study for ECAT HRRT PET Scanner (K040933)

Based on the provided 510(k) summary for the ECAT HRRT PET Scanner (K040933), the device's acceptance criteria and the study proving its performance are described below. It is important to note that the provided document is a summary and does not contain detailed study protocols or comprehensive data.

1. Acceptance Criteria and Reported Device Performance

The 510(k) summary states that "Performance of the ECAT HRRT system has been tested by CPS and found to meet its predetermined PET performance specifications." However, the specific quantitative acceptance criteria or detailed performance specifications are not explicitly listed in the provided document. The document asserts substantial equivalence to predicate devices, implying that the HRRT's performance is at least comparable to or better than the predicate devices (ECAT ACCEL and E.CAM LSO 311).

Without explicit criteria, a table cannot be fully populated. However, based on the general description of PET scanners, typical performance specifications would include:

Acceptance Criteria Category	Reported Device Performance
Spatial Resolution	Not explicitly stated (implied to be improved due to "enlarged data sets (due to increased resolution)")
Sensitivity	Not explicitly stated
Noise Equivalent Counts (NEC)	Not explicitly stated
Count Rate Performance	Not explicitly stated
Image Uniformity	Not explicitly stated
Scatter Fraction	Not explicitly stated
Timing Resolution	Not explicitly stated

The document mentions "enlarged data sets (due to increased resolution)" as a modification handled by the software, suggesting an improvement in resolution compared to the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary does not explicitly state the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The performance testing is described generically as "tested by CPS."

3. Number of Experts Used to Establish Ground Truth and Qualifications

The provided document does not mention the use of experts or the establishment of ground truth for any test set. The performance assessment appears to be based on technical specifications rather than diagnostic accuracy studies involving expert interpretation of images.

4. Adjudication Method

As there is no mention of a test set involving human interpretation or diagnostic outcomes, an adjudication method is not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. The focus is on the device's technical specifications and substantial equivalence to predicate devices. Therefore, no effect size for human reader improvement with AI assistance is provided.

6. Standalone Performance Study

The summary states, "Performance of the ECAT HRRT system has been tested by CPS and found to meet its predetermined PET performance specifications." This implicitly describes a standalone performance evaluation of the algorithm-only (or system-only) without human-in-the-loop performance. However, the details of this testing are not provided.

7. Type of Ground Truth Used

Given that the performance evaluation appears to be based on meeting "predetermined PET performance specifications" rather than diagnostic accuracy, the type of "ground truth" would likely be based on physical phantom measurements, simulated data, or predefined technical benchmarks typically used to characterize PET scanner performance (e.g., measuring spatial resolution from a point source, sensitivity from a uniform phantom). The document does not specify the exact methods.

8. Sample Size for the Training Set

The document does not mention any training set or machine learning components with a quantifiable sample size. The software is based on "Standard ECAT software (7.x)" with modifications for the new acquisition system and larger data sets. This indicates that the software is likely an updated version of a commercially available and established application, rather than a newly developed AI/ML model requiring a specific training set to establish its core functionality.

9. How Ground Truth for the Training Set Was Established

As no training set is described, the method for establishing its ground truth is not applicable or provided.

Summary

{0}------------------------------------------------

510(k) SUMMARY

[As required by 21 CFR 807.87(b)]

K040933

Identification of Submitter Submitter:

Alaine Medio, RAC Senior Regulatory Affairs Specialist CTI PET Systems, Inc. 810 Innovation Drive Knoxville, TN 37932 (865) 218-2703 (865) 218-3019 May 7, 2004

Telephone No: Fax No: Date of preparation:

Identification of the Product

Device Proprietary Name: Common Name: Classification Name:

ECAT HRRT

Positron Emission Tomography (PET) Scanner Emission Computed Tomography System per 21 CFR 892.1200

Marketed Devices to Which Equivalence is Claimed

Device	Manufacturer	510(k) Number
ECAT ACCEL	CTI PET Systems (CPS)	K962797
E.CAM LSO 311	CTI PET Systems (CPS)	K981027

Device Description

A Patient Handling System (PHS) will be offered as an optional accessory with the scanner. This PHS is similar to other PHS systems currently marketed with the exception that it has been specifically designed for use with the HRRT. Modifications have been made to accommodate the different size gantry bore and shorter horizontal travel associated with this gantry.

The acquisition computer system is comprised of an Intel based acquisition PC, a Raid system disk and a console connected via fibre channel to the HRRT electronics. This is the same as is used in the ECAT ACCEL (K002584) with the exception of the RAID disk.

Software is based on the Standard ECAT software (7.x), which is used with the ECAT ACCEL system. Modifications have been made to accommodate the new acquisition system, enlarged data sets (due to increased resolution) and user interface to allow clinician flexibility in reconstruction.

{1}------------------------------------------------

510(k) Summary ECAT HRRT PET Scanner p. 2

Indications for Use

Comparison with Predicate Devices

The ECAT HRRT PET scanner leverages much of the already proven technology, as well as many components and features of currently produced CPS PET tomographic systems. The 360 degree field of view (FOV) detector geometry surrounding the patient port is similar to that of the CPS ECAT ACCEL PET scanner (K002584). The flat panel detectors, LSO/LYSO combined crystal detector technology, and coincidence point source transmission scanning design concepts were borrowed from the E.CAM LSO 311 PET/SPECT system (K981027). The patient handling system (PHS) offered as an option with ECAT HRRT scanner is similar to the PHS used on the CPS ECAT ACCEL. The Advanced Computational System (ACS), used to store and process acquired PET data into sinograms, as well as the reconstruction computer, control console, and the ECAT software are updated versions of those components used in the ECAT ACCEL scanner.

Safety and Effectiveness

The CPS ECAT HRRT system has been designed to comply with applicable industry safety standards for this type of medical equipment including the international standard IEC 60601-1, General Requirements for the Safety Electrical Medical Equipment. Performance of the ECAT HRRT system has been tested by CPS and found to meet its predetermined PET performance specifications.

Substantial Equivalence Determination

In the opinion of CPS, the ECAT HRRT PET scanner utilizes the same scientific technology as the predicate ECAT ACCEL and E.CAM LSO 311 PET/SPECT systems and raises no new questions with regard to its safety and effectiveness. Therefore, we believe the ECAT HRRT is substantially equivalent to those tomographic systems with respect to design, material and composition, energy source, and radiation safety characteristics.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 7 2004

Ms. M. Alaine Medio, RAC Senior Regulatory Affairs Specialist CTI PET Systems, Inc. CPS Innovations 810 Innovation Drive KNOXVILLE TN 37932

Re: K040933 Trade/Device Name: ECAT HRRT PET Scanner Regulatory Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: April 8, 2004 Received: April 9, 2004

Dear Ms. Medio:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k)

I ms letter will and in your to began finding of substantial equivalence of your device to a legally premanted noticated device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you acon office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

{4}------------------------------------------------

Page 1 of 1

510(k) Number (if known):

Device Name: ECAT HRRT PET Scanner

Indications for Use:

CPS ECAT positron emission tomography (PET) scanners are intended to be utilized by CFS ECA I position cimission comography (2017) (2017) 11:50 PM asure the distribution of appropriately transo neanth care professionals to the purpose of determining mychou position entiting siologic functions within the human body.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Nancy C. Sarglon (Optional Format 1-2-96)

(Division Sign-Off) Division of Reproductive, A and Radiological Devices 510(k) Number Page

Regulation Number and Section

N/A